The policies of academic health centers (AHCs) for human subjects protection in the collection, storage, use, and sharing of biospecimens and associated data (i.e., biobanking) will have significant effects on the country's capacity to advance genetic science through collaborative multi-institutional research. Variation in policies for core issues such as informed consent to obtain biospecimens and sharing biospecimens and/or data across institutions can impede or prevent collaborative research. Our preliminary data suggest that this is already occurring. These issues are particularly timely for the NIH's Clinical and Translational Science Awards (CTSA) program, in which AHCs are expected to act as a consortium and collaborate on research. Despite their importance, systematic information on institutional policies is lacking, as is an understanding of the views of key AHC stakeholders about these issues. To address these deficiencies, we propose to: (1) Define the range and variation of policies and practices among CTSA institutions for human subjects protection in biobanking - with emphasis on informed consent and biospecimen/data sharing;(2) Deter- mine the attitudes of stakeholder groups at CTSA institutions (including IRB chairs, CTSA Ethics Directors, investigators) about specific feasible policy options to address barriers to collaboration;and (3) Analyze, through an interdisciplinary process, the ethical and regulatory issues that frame policies on informed consent and sharing biospecimens/datasets across institutions, as well as develop a set of policy recommendations. To accomplish these goals, we will use rigorous analyses of written policies, surveys with structured questionnaires, semi-structured interviews, and an established consensus development process to address specific policy issues on consent and biospecimen/data sharing. Our multidisciplinary research team has complementary strengths. We have an outstanding expert advisory group and robust linkages with CTSA institutions. The preliminary data strongly support the feasibility of our plans;moreover, they suggest substantial inter-institutional policy differences that stakeholders see as barriers to collaboration. The results will be disseminated broadly and include:1) empirically and conceptually based analyses in scholarly journals and 2) practical policy recommendations (developed with the advisory group, CTSA stakeholders, and other authorities) that facilitate ethically sound, collaborative, multi-institutional genetic research. We believe this project will have high impact. It directly addresses an important problem and barrier to progress toward the ultimate goal of using genomic information to improve human health. It responds directly to ELSI priorities and NIH roadmap goals. Moreover, the findings will provide knowledge that improves our capacity to advance multi-institutional studies, and the results are likely to influence concepts and methods in clinical and translational genetic research. PUBLIC HEALTH RELEVANCE: Collaborative multi-institutional genetic research is pivotal to advancing genetic science, and often involves use of biospecimens contributed by human subjects and stored in repositories (biobanks) - but variation in institutions'policies for human subjects protection in biobanking can impede or prevent such research. This project will provide new knowledge on institutional policies and attitudes of key stakeholders, and will provide policy recommendations that facilitate ethically sound advancement of collaborative genetic research. The project therefore addresses an important problem and barrier to progress toward the goal of using genomic information to improve human health.